Our MDR Medical Device Checker assesses the likelihood of your product falling within the scope of the Medical Devices Regulation (MDR), due to become fully applicable in the EU/EEA on 26 May 2021.

Through a straightforward series of questions, the Medical Device Checker helps with your initial assessment of whether the MDR applies to your product. It is not intended to replace legal advice, which you should seek in any event to confirm the assessment.

What is the MDR?

The MDR is not just about medical devices and their accessories. It also regulates certain products without an intended medical purpose that are similar to medical devices in terms of their function and risk profile.

The MDR will not only regulate more products than are currently caught by the regulatory framework for medical devices; it will also impose stricter compliance requirements. If you're developing a product in the medtech space, you should establish as early as possible, whether it is regulated by the MDR.

Launched by our Life Sciences & Healthcare team's regulatory experts, our MDR Medical Device Checker is designed for companies developing technologies which might be considered or regulated as medical devices – the tech and pharma companies entering the medtech space and medtech start-ups – and their funders.

What will it help me do?

You can use the MDR Medical Device Checker in the initial phase of developing your product launch strategy, to support your own assessment of whether the MDR might apply to your product and/or demonstrate to investors that you have given consideration to compliance. Please note, however, that this tool does not replace appropriate regulatory due diligence.

If used correctly, our MDR Medical Device Checker will help you to avoid unpleasant surprises; compliance with the MDR is associated with significant organisational and financial expenditure. It will allow you to take this into account earlier in your product development journey, and ahead of instructing a regulatory expert who can make a final determination.

The MDR Medical Device Checker will also help you reduce the risk of committing a criminal offence of placing a medical device on the market without a valid CE mark.

How do I use it?

The MDR Medical Device Checker will ask you a series of questions. When you complete them, you will receive a report based on the answers you have given which sets out whether your product is likely to fall within any of the types of products regulated by the MDR.

For best results:

• focus on one item at a time; if your product consists of a number of items (eg a kit comprising several different products), you should run this tool for each one
• read the guidance notes in italics
• use the Chrome browser
• ignore the question numbering; our tool may skip some questions on the basis of your answers, and
• remember that if the tool asks you about what is your product "intended to do", this includes everything you say about the product in your marketing.

If at any point you feel that the right answer is "maybe" or that none of the options offered neatly fit your product, it may be because your product is complicated, or borderline. In that case, please note the question number and contact us.